Recently various media reports have cast the spotlight on the ethics of conducting clinical trials in India, where a vast majority of the population is poor, uneducated and without good access to healthcare and medications and therefore particularly vulnerable.
These concerns are unfounded, according to Dr Vasudeo Ginde, a clinician with over 20 years experience in the Indian clinical research industry and currently president and managing director of Indian-based contract research organisation (CRO) iGATE clinical research.
On the subject of informed consent, the distinction needs to be established between intellect and education - just because a person is not educated in the traditional sense of the word, does not mean they do not have the intellectual capacity to be educated, and understand the education, Dr Ginde told Outsourcing-Pharma.com.
"If the clinical trial investigator does their job correctly and explains the process and potential risks to the patient in a way they can understand, then the informed consent is valid."
"I'm not saying there are no challenges with conducting ethical trials in India, I'm just saying there is no additional risk of fraud involving patient recruitment compared to places such as in the US."
Indeed, a number of allegedly fraudulent clinical trial episodes have been surfacing from the US of late.
In August Canadian researchers published an article launching a scathing attack on the growing incidence of North American healthcare professionals being paid exuberant 'finder's fees' whenever they recruit a patient onto a clinical trial.
According to the article, more and more clinicians are being paid recruitment incentives by CROs and trial sponsors in a desperate bid to fill clinical trial quotas.
Concerns over the practice are numerous and include the possibility of clinicians being influenced or driven to act fraudulently by the incentives, as well as inappropriately enrolling patients, against the best interest of both the patient and the trial outcome.
The authors point to the example of a hospital in Albany, New York, where an investigation by the Food and Drug Administration (FDA) uncovered altered patients' medical records in five clinical trials, in order to enrol patients who didn't meet the required eligibility criteria.
The hospital was receiving a fee of $5,000 (€4,000) for each patient enrolled, and some individual investigators also received undisclosed incentives, said the article.
Another recent example is in the case of French firm Avenits's antibiotic drug Ketek - which was found to have links to liver failure - that was allegedly approved on the back of fraudulent clinical evidence.
Doctors were paid $100 for each patient they signed up, another $150 when they submitted study results, and a final $150 after all questions were resolved.
However, the investigator at the highest enrolling site was found to be attracting patients by advertising weight-control treatments and enrolling them when the clinic was closed, and patient consent forms had date modifications and signature inconsistencies.
Both these cases led to criminal prosecution and prison terms for those investigators who were found guilty.
In addition, healthy patients who participate in clinical trials in Western countries often get paid significant 'compensation' for doing so, incentivising many, particularly students and low income earners, to participate in a trial purely for the money, without considering potential health risks.
At the extreme end of this is a worrying trend of some people becoming what is termed a "professional patient."
On the issue, Dr Ginde commented: "In India we don't pay patients to participate in clinical trials, as we don't want to be perceived as buying off poor patients."
"Participants may receive a small compensation for their time, but in a survey carried out in 2004, the real incentive for most people volunteering for a trial is increased access to clinicians."
In India the patient load is so high that most clinicians have only five minutes to spend with each patient on average. Some diabetologists have over 100,000 patients on their books.
"During a clinical trial, that same doctor would spend half an hour with the patient," said Dr Ginde."That amount of attention and quality of care is the real driver for most Indian trial participants."
Furthermore, India does not allow first-in-man studies to be carried out by foreign pharmaceutical companies in India.
"India's regulators have not yet reached a level where they are confident with adequately monitoring such activities," said Dr Ginde.